Approval for a change in repetition rate from 200 Hz to 400 Hz. The device, as modified, will be marketed under the trade name ALLEGRETTO WAVE EYE-Q Excimer Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) in patients who are 18 years of age or older: 1) for the reduction or elimination of myopia of up to -12.0 diopters (D) of sphere and up to -6.0 D of astigmatism at the spectacle plane in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery; and 2) for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.

_________________Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato

STERLING, Va. ? The Food and Drug Administration had granted U.S. marketing approval to WaveLight Inc. for its latest-generation wavefront-optimized excimer laser system, the company announced in a press release.

The approval covers the 400 Hz Allegretto Wave Eye-Q excimer laser for use in LASIK to correct myopia up to ?12 D with up to ?6 D of astigmatism, as well as for hyperopic corrections up to 6 D with up to 5 D of astigmatism, according to the release.

The FDA based the approval for myopic indications on data from U.S. clinical trials involving 901 eyes. At 3 months, stability analysis for 844 eligible eyes showed 98% achieved an uncorrected visual acuity (UCVA) of 20/40 or better, and 84.4% achieved 20/20 or better.

The hyperopia treatment indications were based on data for 290 eyes. At 6 months, stability analysis for 212 eligible eyes showed 95.3% achieved an UCVA of 20/40 or better, and 67.5% achieved 20/20 or better.

The 400 Hz repetition rate allows the Allegretto Wave Eye-Q to deliver 1 D of correction in 2 seconds with a 6.5-mm optical zone, according to the release. The reduced treatment time allows for shorter, more comfortable procedures and may be particularly beneficial for treating high myopia, high astigmatism or other time-intensive procedures, company officials noted.

_________________Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato

Who is online

Users browsing this forum: No registered users and 1 guest

You cannot post new topics in this forumYou cannot reply to topics in this forumYou cannot edit your posts in this forumYou cannot delete your posts in this forumYou cannot post attachments in this forum